Download 1 Contents Chapter 1 Introduction

1
Contents
Chapter 1
Introduction.......................................................................................................................................... 5
Introduction
6
How to Use This Manual
6
Symbols
7
Holmium Laser Theory of Operation
8
Laser Power Parameters
9
Energy Density
10
Unique Features of the Odyssey 30 B
10
System Specifications
11
Chapter 2
Installation...........................................................................................................................................13
Installation
14
Unpacking the Laser System
14
Component Checklist
14
Optional Accessories
15
Registering Your Laser System
15
Transportation and Storage Conditions
16
Electrical Requirements
16
Ambient Operating Conditions
17
Space Requirements
18
Initial System Power ON
18
Verifying Alignment and Calibration
19
Uninterruptable Power Supply
21
Chapter 3
Safety.....................................................................................................................................................23
Introduction
24
Optical Hazards
24
Electrial Hazards
25
Delivery System Related Hazards
25
Other Hazards
25
Safety Indicators
26
Labeling
26
2
Table of Contents
Chapter 4
Fiber Optics.........................................................................................................................................31
Introduction
32
Care and Handling
32
Blast Shields
32
Choosing the Ideal Delivery System
33
Chapter 5
Indications...........................................................................................................................................35
Physician Training
36
General Information and Precautions
37
Urology
39
Chapter 6
Operation.............................................................................................................................................43
Introduction
44
Navigating the User Interface
44
User Power Settings Screen
44
Status Icons
45
User Options Screen
46
Power Matrices: 47
Preparation
49
Procedure Environment
49
Start-up Sequence
50
Adjusting the Screen Contrast
50
Setting Power Parameters
51
Treatment
52
Shut-down Sequence
52
Resetting the Emergency Stop
53
Chapter 7
Maintenance.......................................................................................................................................55
Preventive Maintenance
56
Other Regular Maintenance
56
Troubleshooting Error Codes
57
Troubleshooting Problems Without Error Codes
61
Blast Shield Maintenance
62
Inspecting the Blast Shield
62
Power Calibration
63
Odyssey 30 B User’s Manual
3
Table of Contents
Chapter 8
Customer Service..............................................................................................................................65
Customer Service and Warranty
66
4
© 1999-2008 Xintec Corporation dba Convergent Laser Technologies. All rights reserved.
Odyssey 30 B User’s Manual
Cook Urological Document No. U_Ody30_EN_CE_REV1
No part of this manual may be reproduced, stored in a retrieval system, or transmitted in any form or
by any means, electronic, mechanical, recording, or otherwise, without the prior written permission
of Cook® Urological, Inc.
The content of this manual is furnished for informational use only and is subject to change without
notice.
Odyssey 30, IQ Connector, and OptiLite are trademarks of Convergent Laser Technologies and Xintec
Corporation. This product is protected by US Patent 4,950,268; 5,269,778; 5,689,520; other patents
pending.
Manufactured by:
Cook® Urological, Inc.
Cook® OB/GYN
1100 West Morgan Street
Spencer, IN 47460 USA
Printed in U.S.A.
January 2008
Odyssey 30 B User’s Manual
0088
Cook Ireland LTD.
O’Halloran Road
National Technology Park
Limerick, Ireland
5
1
Introduction
6
CHAPTER 1
Introduction
Introduction
The Odyssey surgical laser system and accessories are designed for use in the
treatment of soft tissue disease and urinary stones. The laser system emits a
concentrated beam of invisible radiation that may cause injury to the user or
patient if improperly used. Prior to operating the laser system, the user and
operating room personnel should be familiar with laser safety and the proper
use of the laser system and its accessories. The user should carefully read and
understand the contents of this Manual and accompanying documentation before
using the laser to treat a patient.
How to Use This Manual
Chapter 1, “Introduction,” introduces the Odyssey laser system and its theory of
operation.
Chapter 2, “Installation,” outlines the procedure for site preparation and installation
of the laser system.
Chapter 3, “Safety,” provides information on regulatory compliance and the safe
use of the laser system.
Chapter 4, “Fiber Optics,” explains the delivery system and provides information for
care and handling of fibers.
Chapter 5, “Indications” provides the physician with precautions, indications, and
contraindications related to the intended use of the laser system.
Chapter 6, “Operation,” describes laser system controls and indicator signals. This
chapter also outlines standard operating procedures.
Chapter 7, “Maintenance,” provides maintenance procedures and a
troubleshooting guide.
Chapter 8, “Customer Service,” contains contact information for ordering
accessories, obtaining warranty repair, or general service requests.
Odyssey 30 B User’s Manual
CHAPTER 1
Introduction
Symbols
The following table lists the symbols used on the laser system and within this
Manual. The placement of the labels are diagrammed in Chapter 3. Additional
symbols used on the touch screen interface are described in Chapter 6.
!
Refer to Manual for
additional instructions
or warnings
WARNING
Dangerous voltage
WARNING–Visible and
invisible laser radiation
STOP
AP
Non-AP equipment
Type BF medical
equipment
Emergency Stop
Alternating current
MAINS ON
isolation transformer energized
MAINS OFF
no power to entire
laser system
Key switch OFF
isolation transformer may
be energized
Standby state
Ready state
Remote interlock
Optical fiber applicator
Foot switch
laser activation device
7
8
CHAPTER 1
Introduction
Holmium Laser Theory of Operation
The Odyssey is a pulsed holmium YAG laser emitting laser radiation at 2100 nm.
The holmium wavelength is highly absorbed by water making it superior for tissue
ablation with minimal lateral thermal damage. In the case of laser lithotripsy, laser
energy vaporizes water in the calculus causing it to crumble into smaller particles
that pass easily through the urinary tract.
A laser, an acronym for Light Amplification by Stimulated Emission of Radiation,
produces a highly concentrated beam of light of a given wavelength. In contrast,
white light, such as sunlight, is composed of light throughout the electromagnetic
spectrum—from ultraviolet (UV), through visible light (i.e. the rainbow), to infrared
(IR).
Laser energy is generated by converting electrical energy to light energy using a
flash lamp. The flash lamp energy is then used to excite the lasing medium, in this
case a holmium YAG laser rod. The laser energy is amplified in the laser resonator
cavity and a small portion of the energy is allowed to leak out. This becomes the
working laser beam.
The Odyssey is a flash lamp
pumped solid-state laser.
The flash lamp converts
electrical energy to optical
energy and the resonator
mirrors amplify the optical
energy.
Output Coupler Mirror
High Reflector Mirror
Holmium YAG Laser Rod
Odyssey 30 B User’s Manual
Flash Lamp
Working Beam, 2100nm
CHAPTER 1
Introduction
9
Laser Power Parameters
Lasers are useful in medical applications because of selective absorption of their
energy by tissue. Since a laser emits light energy at a distinct wavelength, a laser
wavelength is chosen that best matches the desired absorption characteristics for
the target tissue.
In general, holmium lasers (2100 nm) are better at ablating tissue than Nd:YAG lasers
(1064 nm) because the holmium wavelength is readily absorbed by water, which
constitutes a major portion of tissue. However, the Nd:YAG wavelength transmits
easily through water, making it more suitable for coagulation and for generating
thermal effects. The erbium laser (2940 nm) is superior at ablation, but the lack of
commercially available fiber-optics makes it unsuitable for endoscopic procedures.
Power
Pulse Peak Power [W]
Pulse Duration [µs]
Pulse Energy [J]
Water Absorbtion
Coefficient (log 10)
Er:YAG
Ho:YAG
Nd:YAG
1064
2940
2100
Laser Wavelength (nm)
Though laser wavelength is the primary governing factor in tissue interaction, the
mode of laser delivery, or power parameter, determines its clinical effectiveness.
For pulsed lasers like the Odyssey, the mode of laser delivery depends on the pulse
peak power, energy density, pulse duration, and repetition rate.
Most pulsed laser systems are rated by their highest attainable average power.
Average power (P, measured in Watts) is calculated by multiplying the pulse energy
(E, measured in Joule per pulse) with the repetition rate (f, measured in pulses per
second or Hz). For example, the Odyssey 30 is capable of delivering 3.0 J/pulse
at 10 Hz making it a 30 Watt laser system. Note that useful laser power should be
measured at the operating plane and not out of the laser resonator cavity.
A laser’s water absorption
characteristics coupled
with the mode of laser
delivery governs its
clinical efficacy.
10
CHAPTER 1
Introduction
Energy Density
Energy density is one of the most important laser operating parameters for safe
and effective laser surgery. Energy density is proportional to the pulse energy and
inversely proportional to the square of the beam diameter.
For example, switching from a 400 µm (micron) core fiber (0.4 mm) to a 200 µm
(micron) core fiber (0.2 mm) results in an energy density that is four times greater
than before.
The selection of appropriate power parameters is dependent on the procedure,
the selection of delivery system, and the specific conditions of the patient. Before
using the laser system on a patient, the user should have attended a training
course on the specific procedure and have consulted fellow physicians on the
latest clinical techniques, indications, and contraindications.
energy density [J/cm2] ∞
pulse energy [J]
beam diameter [µm]2
Unique Features of the Odyssey 30 B
•
Controlled Delivery—Microprocessor controlled delivery insures precise power
delivery and pulse-to-pulse uniformity.
•
Ease of Use—Touch screen user interface reduces the number and type of
controls to a bare minimum. A status line at the bottom of the screen alerts
the user in the event of a safety hazard or system error. Motorized blast shield
facilitates blast shield changes without removing any access panels.
•
273 µm Fiber Capable—Specially designed optics and mounts allow laser
energy to be delivered into a straight 273 µm core fiber without the need for
expensive tapered fibers.
•
Variable Pulse Duration—Allows the user to easily change the mode of laser
delivery and shift between ablative or coagulative tissue effects.
•
Safety—A safety monitor continuously monitors every subsystem and
automatically sets the laser system to Standby state in the event a potential
hazard is detected.
Odyssey 30 B User’s Manual
CHAPTER 1
Introduction
System Specifications
Model
Laser Type
Laser Wavelength
Maximum Output Power1
2100 nm
30 W
1.14 to 7.1 KW
Pulse Duration
350 or 700 µs
Pulse Energy
0.4 to 3.0 J
Repetition Rate
5 to 20 Hz
Laser Output
Nominal Ocular Hazard Distance
Visible Aiming Beam
25° cone angle
Gaussian
5.64in (14.33cm)
Variable intensity 3 mW green, 532 nm
Laser Activation
Foot switch
Cooling System
Self-contained water-to-air
Physical Dimensions
Weight
102 cm H x 40 cm W x 84 cm D
(40” H x 16” W x 33” D)
90 Kg (200 lb)
Electrical Requirements2
115/230 V~ 50/60Hz
Regulatory Compliance
US CFR 1040.10, 1040.11
Safety Compliance
2
Pulsed CTH:YAG (holmium:YAG)
Pulse Peak Power
Beam Divergence
1
Odyssey 30
UL/CSA 2601, EN 60601-1-1, EN 60825-1,
EN 60601-2-22, EN 60601-1-2 (EMC)
30 W average power achievable with 230 V~ input and 550 µm core fiber.
See Chapter 2 for more complete electrical requirements.
11
12
CHAPTER 1
Introduction
This page intentionally left blank.
Odyssey 30 B User’s Manual
13
2
Installation
14
CHAPTER 2
Installation
Installation
The Odyssey laser system, and any uninterruptable power supply (UPS) used in
conjunction with the laser system, should be installed in a way that optimizes its
usability.
Unpacking the Laser System
Your Odyssey laser system is shipped from the factory in a wooden crate to protect
the laser system from damage during shipping. Before uncrating, inspect the crate
for damage. If there is evidence of damage, save all packing materials and notify
the shipping company by filing an insurance claim report.
After the laser system has been unpacked, please store the shipping crate and
packing materials in a safe location in case the laser system has to be transported
in the future.
Component Checklist
The Odyssey laser system is delivered with the following components or
accessories. Please take inventory of the below items and ensure that there are no
missing items.
•
Odyssey 30 B laser system
•
User’s manual
•
Product performance certificate
•
Dust cover
•
Detachable power cord with NEMA L6-30P plug (for 230 VAC) or NEMA L5-15P
(for 115 VAC).
•
Detachable foot switch
•
Remote interlock connector (attached to laser system)
•
2 operation keys
•
600 µm core test fiber assembly with flat tip
Odyssey 30 B User’s Manual
CHAPTER 2
Installation
Optional Accessories
The following list includes the most common accessories used with the Odyssey.
Please refer to Cook’s product catalog for additional information and pricing.
HLA-2000
Holmium Laser Radiation Warning Sign
HLA-2010
Holmium Laser Safety Glasses
HLA-2020
Holmium Laser Safety Goggles
HLF-S273-CNV
273 µm single use laser fiber with flat tip
HLF-S365-CNV
365 µm single use laser fiber with flat tip
HLF-S550-CNV
550 µm single use laser fiber with flat tip
HLF-S940-CNV
940 µm single use laser fiber with flat tip
HLF-M273-CNV
273 µm multi-use laser fiber with flat tip
HLF-M365-CNV
365 µm multi-use laser fiber with flat tip
HLF-M550-CNV
550 µm multi-use laser fiber with flat tip
HLF-M940-CNV
940 µm multi-use laser fiber with flat tip
Registering Your Laser System
Please be sure to register your laser system with your local distributor. Please
include the serial number of your laser system when contacting them.
By registering your laser system, you will be notified of product safety bulletins
and updates to the software and documentation.
15
16
CHAPTER 2
Installation
Transportation and Storage Conditions
In transit the laser system must be packaged to protect the enclosures from
damage; such as in the original shipping crate. If the original shipping crate is
not used for transportation the system must be secured to prevent damage. The
handles can be used to tie the system to a secure surface; the enclosure should
NOT be used for this purpose. The enclosures should not be subjected to excessive
force, shock or vibration. If shock or vibration are suspected the laser alignment
should be inspected by a trained technician.
If any water remains in the cooling system the laser must not be subjected to
freezing temperatures. Storage and transit temperature must not exceed 43° C
(110°F). Storage humidity should not exceed 95%. If the laser is stored in a high
humidity location it must be allowed sufficient time to reach equilibrium when
introduced to a cool operating environment. Failure to do this may result in
damage to the optics from condensation.
Electrical Requirements
The Odyssey is equipped with a worldwide tappable isolation transformer, which
can be configured to suit your line voltage conditions. The laser system will
perform optimally if it has its own dedicated, stable electrical supply line. Measure
the alternating current (“AC”) line voltage with and without load to verify that
the electrical supply line is stable. Please contact customer service to request the
technical bulletin on reconfiguring the transformer.
DANGER—High Voltage—Only a qualified service technician or biomedical
engineer can reconfigure the isolation transformer. A mistapped transformer may
cause serious harm to the technician and/or damage the laser system.
Nominal Outlet Voltage
115 V~
230 V~
Voltage Range
103-127 V~
207-253 V~
Current Rating
15 A
15 A
Maximum Output Power
15 W
30 W
Odyssey 30 B User’s Manual
CHAPTER 2
Installation
The maximum output power is dependent on the line voltage. When the input
voltage is 115 V~, the software limits the output power to 15 W. At 230 V~, the
laser system is capable of delivering full power.
Ambient Operating Conditions
The laser system should be used in a well-ventilated, air-conditioned operating
room. The procedure room temperature should be kept between 18-22° C
(65-72 °F) for optimum system performance. In general, Holmium lasers are very
sensitive to temperature, so the output can vary by up to 15% depending on the
room temperature. The laser system is factory calibrated at 21° C (70°F).
When the laser system reaches above 38° C (100 °F), the safety circuits will prevent
the laser system from operating. The touch screen status readout will display “11:
System Overheat.” The laser system overheats for the following reasons:
•
the ambient operating room temperature is above 24° C (74 °F) ,
•
the laser system has been running at high power for an extended period of
time (greater than 20 minutes), or
•
the input line voltage is lower than normal causing the cooling fans or water
pump to under-perform.
17
18
CHAPTER 2
Installation
Space Requirements
The laser system requires adequate space to reduce potential operating hazards
and allow for proper air ventilation. The cooling system contains two radial fans
located at the bottom of the laser system. Cooling air is drawn from the bottom of
the unit and exhausted through the vents located on the right, left, and back sides
of the laser system. There should be a clearance of at least 1 meter (3 ft) on each
side of the system to allow for proper airflow.
Allow about 1 meter
on all sides of the laser
to allow for adequate
ventilation.
Top View
Front
1m
Rear
!
To reduce potential operating hazard, the laser system should be positioned at
least 1 meter (3 ft) from the patient.
The procedure room should be in a controlled access area. If necessary, install the
remote interlock switch to prevent inadvertent laser exposure to unsuspecting
personnel entering the operating room. A laser danger sign must be posted on
each operating room access door. Please consult your Laser Safety Officer for
applicable laser safety procedures.
Initial System Power ON
Review the previous sections in this chapter and verify that all site installation
requirements have been met. The laser system should only be operated in a
restricted access area. Post a laser danger sign on each access door.
1 Plug the detachable power cord into the laser system.
Odyssey 30 B User’s Manual
CHAPTER 2
Installation
19
2 Verify that the MAINS switch is in the OFF (O) position.
3 Verify that the key switch is in the OFF (O) position.
4 Plug the outlet end of power cord to a suitable electrical outlet.
5 Verify that the remote connector is secured.
6 Plug the detachable foot switch into the connector on the back panel.
7 Raise the fiber mast to the upright position.
8 Turn ON (I) MAINS switch.
9 Turn ON (I) the key switch. The yellow Standby LED is lit. After 5 seconds, the
touch screen displays the user power settings screen.
10 Lift the laser aperture door and insert the 600 µm test fiber into laser aperture.
Do not overtighten the delivery system connector. The connector only needs to be
finger-tight for proper operation.
11 After about 5 seconds, the touch screen status displays “STANDBY” and an
icon appears on screen indicating that a 600 µm core fiber has been properly
connected.
12 Press the Ready button. The green Ready LED is lit.
13 The touch screen status displays “Please Wait ...”
14 If the touch screen status displays “READY” after 2 seconds, then the system is
operating normally. If not, please consult the troubleshooting guide in Chapter
6 or call for service.
15 Follow the instructions in the next section to verify the alignment and
calibration.
Verifying Alignment and Calibration
The laser system has been designed with many safeguards to prevent optical
misalignment due to shipping and normal operation. However it is important to
verify the alignment and calibration of the laser system to ensure peak system
performance.
!
20
CHAPTER 2
Installation
The following test requires a calibrated energy or power meter. Please contact your
distributor if you would like to know if your energy or power meter is compatible
with the Odyssey.
!
The test below is intended for laser systems operating at 230 V~ nominal. Skip step
12 if you are operating the laser system using a 115 V~ electrical outlet.
1 Setup laser system for lasing.
2 Verify that the 600 µm test fiber has clean surfaces on both the connector and
distal ends.
3 Insert the 600 µm test fiber into the laser aperture.
4 Wear appropriate safety eyewear. See Chapter 3.
While the laser is in operation, all personnel in the operating room must wear
appropriate laser eyewear. The working beam is invisible and can cause irreparable
eye damage. Do not stare into the beam, even through laser eyewear.
5 Setup energy/power meter probe in front of and parallel to the distal face of
the test fiber. Be careful not to place the fiber tip too close to the probe as the
energy density may damage the probe’s sensitive surface.
Do not place the distal tip
of the fiber too close to the
probe as the high energy
density may destroy the
probe’s sensitive coatings.
Measuring
Plane
Fiber Distal End
3-6 cm
6 Set the power parameters to 350 µs, 7 Hz, 0.5 J (3.5 W).
7 Press the Ready button and wait 2 seconds.
8 Depress the foot switch for 5-10 seconds until you get a stable reading on your
energy/power meter.
9 If the power reading is not within 10% of the displayed power, the laser system
is either misaligned or out of tune. Please call for service.
Odyssey 30 B User’s Manual
CHAPTER 2
Installation
21
10 Repeat steps 7-9 for 350 µs, 10 Hz, 1.5 J (15 W).
11 Inspect connector end of fiber for burn marks. If there is a burn mark, the laser
system is out of tune. Please call for service.
12 (230 V~ systems only) Repeat steps 7-9 & 11 for 350 µs, 10 Hz, 3.0 J (30 W).
13 Follow instructions in Chapter 6 to shut down the laser system.
If you receive an under-power warning message, the most likely cause is that the
resonator mirrors are slightly out of alignment. The laser will continue to operate
normally. Call for service at next opportunity.
Uninterruptable Power Supply (UPS)
Consult the UPS users manual for information on safe installation. Ensure that the
UPS is safely installed prior to use with the laser system.
!
22
CHAPTER 2
Installation
This page intentionally left blank.
Odyssey 30 B User’s Manual
23
3
Safety
24
CHAPTER 3
Safety
Introduction
This chapter contains important safety information related to the use of the laser
system. All operating room personnel should familiarize themselves with the
contents of this chapter before operating or assisting in the operation of the laser
system. All efforts have been made to minimize hazardous conditions during
system design. However, since the laser system is high power equipment, it is
impossible to eliminate all potential hazards that may result in user and patient
injury.
The Odyssey is classified as a Class IV laser system by the National Center for
Devices and Radiological Health (CDRH). Class IV represents the highest class of
laser devices. Laser energy should only be applied to the intended treatment area.
!
Read this manual carefully. The performance of procedures, controls or
adjustments other than those specified herein may result in hazardous radiation
exposure.
Optical Hazards
•
All persons in the operating room must wear appropriate safety eyewear while
the laser is in operation. Appropriate eyewear includes safety spectacles
and goggles with an Optical Density of 4 or greater.
•
The working beam is invisible and can cause irreparable eye damage. Only
direct the optical fiber at the intended surgical site.
•
Eye damage can occur not just by direct viewing of the working beam but also
through scattered laser radiation when reflected off smooth surfaces such as
operating room walls, floors, and other surgical equipment.
•
Do not look directly at the distal end of the optical fiber or into the laser
aperture.
Odyssey 30 B User’s Manual
CHAPTER 3
Safety
Electrical Hazards
•
Only a qualified service technician may remove the enclosure covers.
Removing the enclosures exposes personnel to potential electrical hazards.
There are no user-serviceable parts within the laser system.
•
Do not touch areas marked HIGH VOLTAGE. These and surrounding
components in the laser system contain charge voltages of up to 1000 VDC.
•
Do not operate the laser system or the UPS if the procedure room floor is
flooded.
Delivery System Related Hazards
•
The use of incorrect or broken fibers may result in injury to the user or the
patient due to inadvertent laser exposure.
•
The use of incorrect, damaged or soiled fibers may result in damage to the
laser system (blast shield and output lens) and to the endoscope in use.
•
Check fibers regularly for damage. See Chapter 4 for more information.
Other Hazards
•
RISK OF FIRE—Do not direct the distal end of the fiber on flammable materials
such as surgical drapes.
•
RISK OF EXPLOSION—Do not operate the laser system in the presence of
flammable substances including flammable anesthetics.
•
Electromagnetic Interference—There is a risk of interference when the laser
is used in conjunction with other electronic devices. Use of an Uninterrupted
Power Source (UPS) is required to comply with IEC 60601-1-1. Specifically,
regulations require the use of the Smart UPS-3000, made by APC, or a unit
which has the same funtionality and appropriate medical certifications and
approvals.
•
Unauthorized Use—The laser system is designed to be used and serviced by
trained individuals. To protect against damages from unauthorized use remove
the key from the key switch and make it available only to qualified technicians
and operators.
25
26
CHAPTER 3
Safety
Safety Indicators
!
!
•
Standby yellow LED, located on the Standby button on the control panel,
indicates that the laser system is in Standby state. Depressing the foot switch
will NOT activate the laser.
•
Laser Ready indicator green LED, located on the Ready button on the control
panel, indicates that the laser system is in Ready state—no system errors are
present and the touch screen is displaying the user power settings screen.
Depressing the foot switch will activate the laser.
When switching from Standby state to Ready state, there is a two second delay to
allow time for laser operator to give adequate notice to operating room personnel.
•
Capacitor charge indicator icon, located on the lower right corner of the touch
screen display, indicates whether the main capacitor bank has no charge, is
half charged, or is fully charged.
•
Audible emission warning alerts operating room personnel that the laser is
firing.
•
Visible emission indicator (blinking amber LED), indicates that the laser is
firing. The audible and visible emission indicators operate simultaneously.
•
Status readout, located on the lower left corner of the touch screen display
alerts the user of any internal system errors. The error codes are referenced in
Chapter 7.
In the event of a system error, the laser system will immediately return to Standby
state and the Status readout will display a corresponding error code.
Labeling
The Odyssey contains all appropriate labels to satisfy U.S. Food and Drug
Administration (FDA), Underwriter’s Laboratory (UL), European Union (CE), and
Canadian Standards Assocation (CSA) medical laser device labeling requirements.
Odyssey 30 B User’s Manual
CHAPTER 3
Safety
Visible emission indicator—
blinks when laser is operating
Laser ready indicator—
laser ready to fire when
green LED is lit
READY
Ready button—
set laser system
in Ready state
STAND BY
Standby button—
sets laser system in
Standby state
LASER APERTURE
laser aperture—laser radiation
is emitted from this aperture
laser aperture door UP:
open position
laser aperture door lever
laser aperture door DOWN:
closed position
fiber-optic
connector port
LASER TECHNOLOGIES
Odyssey 30 B Front View
27
28
CHAPTER 3
Safety
STOP
Emergency Stop—hit the
emergency stop to cut all
electrical power to the laser
system.
!
DANGER
VISIBLE & INVISIBLE LASER RADIATION
WHEN OPEN AND INTERLOCKS DEFEATED
AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADIATION
STOP
40W MAX AT 2100nm
3mW MAX AT 532nm
CLASS 4 LASER PRODUCT
CONFORMS TO IEC 60825-1:1993+A1:1997
(located on the lower right side door)
Odyssey 30 B Top View
Odyssey 30 B User’s Manual
CHAPTER 3
Safety
top panel lock
Key switch
Access to dangerous
voltages if top panel is
removed
CAUTION
REMO
REMOTE
INTERLOCK
!
INTERLOCK
REMOTE
INTERLOCK
FOOT SWITCH
Mains:
115/230
115/230V~50/60
Hz, 15A
Manually configured
FOOT SWITCH
Model No.:
Odyssey 30
Serial No.:
29020.0001
Manufactured: August 1999
!
See Chapter 2 for electrical
requirements
CONVERGENT LASER TECHNOLOGIES
Mains:
115/230 V~ 50/60 Hz, 15 A
Manually configured
AP
Model No.:
Serial No.:
Manufactured:
Odyssey 30
29020.0001
August 1999
DANGER–Risk of explosion
if used in the presence of
flammable anesthetics
MAINS switch
Type BF Equipment
This product complies with 21 CFR 1040.10 and 1040.11 as applicable.
This product is protected by US Patent Nos 4,950,268; 5,269,778; 5,689,520;
other patents pending.
CONVERGENT LASER TECHNOLOGIES
1660 South Loop Rd, Alameda CA 94502
Made in the U.S.A.
MAINS appliance inlet
AP
DANGER–Risk of explosion
if used in the presence of
flammable anesthetics
Type BF Equipment
This equipment is designed to
provide an adequate degree
of protection against electric
shock, particularly regarding
allowable leakage currents and
reliability of the protective earth
connection.
Odyssey 30 B Back View
29
30
CHAPTER 3
Safety
The following labels are found inside the laser system. Only a certified technician is
authorized to remove the enclosures.
!
DANGER
Visible and invisible laser radiation
when open and interlocks defeated.
AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADITION.
Class 4 laser product.
•
This explanatory label is located on the cover of the optical platform and on the
resonator chamber. When these interlocked covers are removed, hazardous laser
radiation may be emitted from the laser head into the operating room.
•
Access to this panel is restricted to authorized service personnel.
•
This label indicates dangerous voltage. Systems bearing this label must be
accessed with caution.
•
These systems include the AC Distribution System and the High Voltage
Capacitor Bank.
•
This label indicates a ground connection.
•
Low Voltage Power Supply and the AC Inlet/MAINS are connected to the
chassis.
Odyssey 30 B User’s Manual
31
4
Fiber Optics
32
CHAPTER 4
Fiber Optics
Introduction
Your Odyssey Laser System is designed for use with Cook OptiLite optical fibers
exclusively. The use of any alternative delivery system may result in user or patient
injury, or damage to the laser system and will void the warranty (see Chapter 8).
The delivery system affects the patient, the user, and the laser system and
therefore must be treated with care.
Care and Handling
All optical fiber assemblies are fragile. While smaller fibers are more flexible, all
sizes are prone to fracture. Do not bend fibers to a diameter of 5 inches (12.7cm) or
less. Do not apply excessive pressure.
Use of broken fibers may cause injury to the system or the patient. Ensure the
integrity of the delivery system prior to use. Using the aiming beam or an HLA2300 Fiber Inspection Microscope, check for any light escaping along the length of
the fiber or for unusual dimness from the distal end.
The connector end of the fiber assembly is also fragile, and must be kept clean.
Any dust, dirt, oil, or scratches on the connector can cause costly damage to the
laser. Never touch the connector surface with bare hands. Do not use a fiber if the
connector may be soiled or damaged. Always replace the connector cap when the
fiber is not connected to the laser system.
The distal end is sharp and will damage articulating endoscopes if not threaded
through carefully. Extend the distal end of the fiber through the working channel
of the endoscope only when the endoscope is straight. If the endoscope must be
articulated to visualize the calculus, straighten it to extend the distal end of the
fiber through. Then articulate the endoscope to bring the calculus back into view.
Blast Shields
Each Odyssey Laser is equiped with a disk of six blast shields which protect the
output lens from flash back debris. Normally, each blast shield should last over 100
cases, but they can be easily damaged by using dirty, scratched or inapropriate
delivery systems. Continued use of a soiled blast shield will damage the output
lens.
Odyssey 30 B User’s Manual
CHAPTER 4
Fiber Optics
Damaged fibers can be both a cause and a symptom of a soiled blast shield. If a
fiber is suspected to be damaged after use with the laser, rotate the blast shield
disk (see Chapter 7) and alert a technician that a blast shield may be soiled.
Choosing the Ideal Delivery System
Cook OptiLite delivery systems come with 273, 365, 550, or 940 µm core diameters.
Larger cores will provide more power, but are less flexible. Users are encouraged
to select the largest core feasable considering the flexibility needed to reach the
target, and the size of the endoscope’s working channel.
33
34
CHAPTER 4
Fiber Optics
This page intentionally left blank.
Odyssey 30 B User’s Manual
35
5
Indications
36
CHAPTER 5
Indications
Physician Training
Physician training should include all of the following areas, which are often
performed chronologically in the order listed below:
1 The physician should thoroughly review published literature related to the
holmium laser procedures. These include literature pertaining to general
laser biology and specific treatment techniques for a particular disease entity.
The physician should also review similar modalities in related specialties and
similar indications using other types of lasers such as Nd:YAG, Er:YAG and CO2
wavelength lasers.
2 The physician should attend training courses and seminars at medical
conferences related to holmium laser procedures. At these conferences, there
are a number of courses on laser therapy which discuss the latest surgical
techniques, precautions, indications, and contraindications.
3 The physician should attend hands-on workshops offered at medical
conferences or available in your local area.
4 The physician should attend didactic courses that include both seminar and
laboratory sessions.
5 Where possible, the physician should visit other physicians who are
performing similar or related laser therapy to observe cases and discuss
different aspects of the procedures.
Odyssey 30 B User’s Manual
CHAPTER 5
Indications
General Information and Precautions
Indications
The Odyssey laser system and accessories are intended solely for use by properly
trained and qualified physicians. The laser system is indicated for use in urology.
The use of the laser system for an application is at the physician’s discretion except
in cases where contraindicated.
Warnings
• Unexpected or uncontrolled tissue damage can sometimes occur due to
excessive power application. Use only the lowest pulse energy settings
required to achieve the desired tissue effects. Extreme caution should be
employed until the biological interaction of the laser energy with tissue is fully
understood by the physician.
•
As with conventional endoscopic and laparoscopic treatment, the possibility
of adverse reactions such as chills, fever, edema, and hemorrhage may
occur following treatment. In extreme cases, death may occur either due to
procedural complications, concurrent illness, or laser application.
Precautions
Use caution with patients who have had difficulty with previous endoscopic or
laparoscopic procedures.
•
•
The laser should be used only on a tissue target that is fully observable either
by direct sight or through an endoscope.
•
Vaporization or excision of anatomical structures in proximity to known critical
structures such as large arteries, veins, bowel, ureter, bladder, etc. should be
performed carefully to avoid damage to such structures.
•
Electrocautery should be easily accessible in the event that a bleeding artery
or vein needs to be cauterized.
•
The flammability of methane gas must be considered when treating in the
perianal area.
Clinical Parameters
• The holmium laser wavelength (2100 nm) has been shown to be a safe and
effective tool for ablation, excision, and coagulation of a variety of soft tissues
as demonstrated by numerous clinical studies and pre-clinical experience. The
depth of laser incision is dependent on the power parameters (see Chapter 1).
37
38
CHAPTER 5
Indications
The rate of incision is dependent on the pulse frequency or repetition rate.
Optimum incision of tissue is accomplished by balancing the depth and rate of
the incision being formed.
•
If a surgical probe is used in contact mode with the tissue, the localized
heating may cause the distal end of the fiber to deform.
•
Please consult the specific sections of this chapter for additional clinical
information. The most up-to-date clinical indications can be collected through
the sources listed in the Physician Training section of this chapter.
Usage Recommendations
• The holmium laser wavelength is strongly absorbed by water and is generally
considered as an effective tool for tissue ablation with minimal lateral thermal
damage.
!
•
When the surgical probe is used in non-contact mode, the working beam is
diverging at approximately 25°. The energy density decreases as the distal
tip moves further from the target tissue (see Chapter 1). Approximately 2-30%
of the working beam may be lost to backscatter of which a portion may be
absorbed by non-targeted peripheral tissue.
•
When using the surgical probe in contact mode, place the distal tip in contact
with tissue before activating the laser. Discontinue power delivery as the fiber
tip is being disengaged from the tissue to minimize the adhesion of tissue to
the fiber tip.
•
When selecting power parameters, always select the lowest power parameters
to achieve the desired tissue effect. Start with the lowest reasonable setting
and gradually increase power if necessary. See Chapter 6 for power selection
methodology.
•
When using the laser within a non-aqueous environment a method of plume
and fume extraction must be considered.
Laser plume may contain viable tissue particulates.
Odyssey 30 B User’s Manual
CHAPTER 5
Indications
Urology
Indications
Incision, excision, coagulation, ablation, therapeutic thermal or photodisruption
of all tissue and treatment of tumors and stones in the genitourinary tract, and
specifically for the fragmentation of upper and lower tract urinary calculi including
cystine, calcium oxalate, monohydrate, and calcium oxalate dihydrate stones.
Warnings
• Extreme caution should be used until the physician is completely familiar with
the biological interactions of laser with various tissue types.
•
Do not operate the laser if the operating plane is not visible either by direct
sight or via an endoscope.
•
Steady the distal end of the fiber at the intended treatment target before
depressing the foot switch.
•
Tissue perforation can occur if excessive laser energy is applied, whether through
excessive pulse energy or extended laser application dwell time. Because fiber
tips are sharp, perforation may occur by mechanical means (poking).
•
When risk of air embolism is present, such as cutting/vaporizing organs with
large vascular structures, always use fluid cooling.
•
Screen tumors that are in close proximity to known arteries or veins by
pretreatment workups to precisely locate the tumors.
•
The risk of combustion, perforation, and laser-induced hemorrhage, any of
which can cause patient death, must be fully explained to the patient prior to
surgery.
•
Endoscopic treatment may result in adverse reactions such as fever, chills,
sepsis, edema, and hemorrhage. In extreme cases, death may occur due
to procedural complications, concurrent illness, or the application of laser
radiation.
Precautions
• Use caution when treating patients who have had difficulty with previous
endoscopic procedures.
•
When radiotherapy and laser therapy are used concurrently, extra precautions
should be taken including conducting more stringent postoperative
39
40
CHAPTER 5
Indications
monitoring. Patients who have undergone radiotherapy present a greater risk
of perforation and tissue erosion.
•
Cook® Medical has no clinical information or experience concerning the use of
the Odyssey on pregnant women or nursing mothers.
•
Patients who have experienced discomfort during previous laser treatment
may require analgesics.
Complications & Risks
The following complications can cause patient death:
•
Non-thermal—Perforation, aspiration, induced hemorrhage, allergic
reaction to medication, hypertension, arrhythmia, pain, gas over-distention,
pneumothorax, and infection.
Thermal Acute—Induced hemorrhage, ulceration, perforation, edema,
pain, fever, leukocytosis, and chills.
Thermal Chronic—Delay in healing, perforation, delayed hemorrhage, and
sepsis.
•
Pain—Short-lived pain may occur immediately following endoscopic laser
therapy and may persist for as long as 48 hours.
•
Fever & Leukocytosis—Immediately after laser therapy, the patient may
experience fever and leukocytosis, which are commonly associated with tissue
destruction. These conditions are generally resolved without treatment. Tissue
cultures are indicated to exclude the possibility of infection.
•
Bleeding—Patients may experience bleeding at the surgical site or from
erosion of a tumor during or after laser therapy. Post treatment blood studies,
such as hematocrit levels, may be necessary.
•
Sepsis—Laser-ablated tissue may become infected after therapy. If a question
of sepsis exists, a culture should be taken and other appropriate evaluations
made.
•
Perforation—Perforation can occur as a result of excessive exposure to laser
radiation. Perforation can also occur from tumor erosion, or as a result of
endoscopic or cystoscopic procedures. To clinically diagnose perforation,
patients must be monitored postoperatively through physical signs,
hematocrit, and radiography.
Odyssey 30 B User’s Manual
CHAPTER 5
Indications
•
Gas Over-distention & Pneumothorax—Patients may experience gastrointestinal
distension or pneumothorax during or after therapy.
Contraindications
The use of the holmium laser is contraindicated for patients:
•
who are inappropriate candidates for laser surgery
•
who are intolerant of anesthesia
41
42
CHAPTER 5
Indications
This page intentionally left blank.
Odyssey 30 B User’s Manual
43
6
Operation
44
CHAPTER 6
Operation
Introduction
The Odyssey laser system user interface is feature-rich and intuitive. The touch
screen display allows you to precisely control your laser parameters. The laser
system is intended for use only by physicians trained in the therapeutic use of
holmium lasers. Before operating the laser, the user should be familiar with the
safety precautions noted in Chapter 3 and the clinical indications noted in Chapter
5. In addition, all operating room personnel should be trained in laser safety.
touch screen
interface
All user controls are
accessible through
the control panel and
touch screen interface.
laser ready
indicator
Standby button
STANDBY
READY
Ready button
Navigating the User Interface
The user mode touch screen interface is separated into two screens: user power
settings screen and user options screen. All necessary operating controls are
located on the user power settings screen. To prevent inadvertent laser exposure,
the laser system can only lase when the touch screen is displaying the user power
settings screen and the laser Ready indicator is ON (lit green).
User Power Settings Screen
AIMING BEAM
Visible aiming beam brightness control
• defaults to OFF in Standby state and defaults to ON in
Ready state
•
•
•
PULSE WIDTH
350
µs
Odyssey 30 B User’s Manual
adjustable in 10 step increments
lowest step is OFF
touch UP to turn ON beam while in Standby mode.
Pulse width (pulse duration) control
•
toggle
between 350 µs and 700 µs
CHAPTER 6
Operation
AVG POWER
4.9
Energy control
• increase or decrease pulse energy in 0.1 J increments
W
REP RATE ENERGY
7
Hz
0.7
J
Repetition rate control
• increase or decrease the pulse repetition rate
Average power display
• average power calculated by multiplying rep rate
(pulse frequency) with pulse energy
STATUS
Standby
Status display
• under normal conditions, displays the operating state
of the system: STANDBY or READY
• under error state, displays the error identification
number
COUNTER
00000
Joule counter
• displays the total amount of energy delivered
• reset button
sets the counter back to zero
User options screen button
• jump to user options screen
Status Icons
Input line voltage indicator
115V
115 V~ line input (also used for 100 V~)
230V
230 V~ line input (also used for 200 V~)
Delivery system indicator
no delivery system connected
200
273 µm fiber assembly connected
400
365 µm fiber assembly connected
600
550 µm fiber assembly connected
1000
940 µm fiber assembly connected
45
46
CHAPTER 6
Operation
Capacitor charge indicator
capacitor voltage between 0 and 50 (no icon)
capacitor voltage between 50 and 400 V
capacitor voltage between 400 and 600 V
capacitor voltage between 600 and 1000 V
User Options Screen
System information
• system serial number
INFO
Serial No.
29020.000
Version No.
V2.19.0
Manufactured
January 2008
•
•
COOLANT TEMP.
70
°F
21
°C
SCREEN CONTRAST
BLAST SHIELD
3
!
software version number
date of manufacuture
Coolant temperature display
• displays the cooling water temperature in degrees
Fahrenheit and Celsius
Screen contrast adjustment
• increase or decrease the touch screen contrast
Blast Shield control
• advance or reverse blast shield disk position between
positions 1 through 6
Unless the Blast Shield is inadvertantly rotated forward, only a trained service
technician should rotate the disk in reverse.
Return button
•
Odyssey 30 B User’s Manual
return to the user power settings screen
CHAPTER 6
Operation
Power Matrices: Bolded numbers are for use in calibration.
350 µs pulse width (power in W)
5 Hz
7 Hz
10 Hz
12 Hz
15 Hz
20 Hz
0.4 J
2.0
2.8
4.0
4.8
6.0
8.0
0.5 J
2.5 3.5
5.0
6.0
7.5
—
0.6 J
3.0
4.2
6.0
7.2
9.0
—
0.7 J
3.5
4.9
7.0
8.4
10.5
—
0.8 J
4.0
5.6
8.0
9.6
12.0
—
0.9 J
4.5
6.3
9.0
10.8
13.5
—
1.0 J
5.0
7.0
10.0
12.0
15.0
—
1.1 J
5.5
7.7
11.0
13.2
16.5
—
1.2 J
6.0
8.4
12.0
14.4
18.0
—
1.3 J
6.5
9.1
13.0
15.6
19.5
—
1.4 J
7.0
9.8
14.0
16.8
21.0
—
1.5 J
7.5
10.5
15.0
18.0
22.5
—
1.6 J
8.0
11.2
16.0
19.2
—
—
1.7 J
8.5
11.9
17.0
20.4
—
—
1.8 J
9.0
12.6
18.0
21.6
—
—
1.9 J
9.5
13.3
19.0
22.8
—
—
2.0 J
10.0
14.0
20.0
24.0
—
—
2.1 J
10.5
14.7
21.0
25.2
—
—
2.2 J
11.0
15.4
22.0
26.4
—
—
2.3 J
11.5
16.1
23.0
—
—
—
2.4 J
12.0
16.8
24.0
—
—
—
2.5 J
12.5
17.5
25.0
—
—
—
2.6 J
13.0
18.2
26.0
—
—
—
2.7 J
13.5
18.9
27.0
—
—
—
2.8 J
14.0
19.6
28.0
—
—
—
2.9 J
14.5
20.3
29.0
—
—
—
3.0 J
—
—
30.0
—
—
—
47
48
CHAPTER 6
Operation
700 µs pulse width (power in W)
!
5 Hz
7 Hz
10 Hz
12 Hz
15 Hz
0.4 J
2.0
2.8
4.0
4.8
6.0
0.5 J
2.5
3.5
5.0
6.0
7.5
0.6 J
3.0
4.2
6.0
7.2
9.0
0.7 J
3.5
4.9
7.0
8.4
10.5
0.8 J
4.0
5.6
8.0
9.6
12.0
0.9 J
4.5
6.3
9.0
10.8
13.5
1.0 J
5.0
7.0
10.0
12.0
15.0
1.2 J
6.0
8.4
12.0
14.4
—
1.3 J
6.5
9.1
13.0
15.6
—
1.4 J
7.0
9.8
14.0
16.8
—
1.5 J
7.5
10.5
15.0
18.0
—
1.6 J
8.0
11.2
16.0
—
—
1.7 J
8.5
11.9
17.0
—
—
1.8 J
9.0
12.6
18.0
—
—
1.9 J
9.5
13.3
19.0
—
—
2.0 J
10.0
14.0
20.0
—
—
2.1 J
10.5
14.7
21.0
—
—
2.2 J
11.0
15.4
22.0
—
—
For 30 Watt systems, the software limits the output power to 15 W using 115 V~
(or 100 V~), 10 W using a 273 µm core fiber, and 20 W using a 365 µm core fiber.
Full power is achievable using 230 V~ (or 200 V~) with a 550 µm or larger core fiber.
15 and 20 Hz are not achievable using a 273 µm core fiber.
Odyssey 30 B User’s Manual
CHAPTER 6
Operation
49
Preparation
1 Make sure that all persons in the operating room have appropriate laser safety
eyewear, see Chapter 3.
2 Verify that the power cord is plugged into to a suitable electrical outlet. For
additional details, please review the installation procedures in Chapter 2.
3 Verify that the MAINS switch, located on the back panel, is in the ON (I)
position.
4 Verify that the foot switch is properly connected. The foot switch connector is
located on the back panel.
5 Verify that the remote connector is attached. The remote connector is located
on the back panel above the foot switch connector.
In case of an emergency, hit the emergency stop button located on the top panel.
When the button is engaged, all electrical power to the laser system will be cut
immediately. Remember to release the emergency stop button before attempting
to restart the laser system.
Procedure Environment
•
Operating room should be well-ventilated and air-conditioned. Ambient
temperature should be between 18-22° C (65-72°F), variance in temperature
may affect laser output.
•
To reduce potential operating hazard the laser system should be positioned at
least 1 meter (3 ft) from the patient.
•
Because the laser is not designed to be sterilized it should be kept outside the
sterile operating field. Extend the sterilized delivery system into the operating
area for use.
•
The UPS used with the laser is also non-sterile and should not enter the sterile
operating field.
•
Do not contact the laser or UPS and patient simultaneously.
!
50
CHAPTER 6
Operation
Start-up Sequence
1 Turn ON the key switch. The key switch is located on the back panel.
2 The laser system powers ON and the touch screen displays the welcome
screen. After 2 seconds, the power setting screen appears.
3 Open the laser aperture door by lifting the handle.
4 Connect the fiber delivery system into the fiber-optic port, located on the
front panel. Make sure that the connector is screwed down finger-tight but
do NOT overtighten the fiber connector. The touch screen displays a fiber icon
corresponding to the fiber core size.
!
If a fiber delivery system is connected when the laser is initially turned ON, the
status displays “RECONNECT FIBER.” Remove and reconnect the fiber. The Status
display will change to “STANDBY.”
5 Adjust the screen contrast as necessary. See Adjusting the Screen Contrast
below.
!
The aiming beam can be turned on in Standby state by pressing the aiming beam
UP arrow button. In Ready state, the aiming beam will turn on automatically unless
it has been manually set in the OFF position.
Adjusting the Screen Contrast
1 From the power setting screen, touch the options button.
2 If the screen is too bright, touch the DOWN arrow until the contrast is
optimum. If the screen is too dark, touch the UP arrow until the contrast is
optimum.
3 Touch the back button to return to the power setting screen.
Odyssey 30 B User’s Manual
CHAPTER 6
Operation
Setting Power Parameters
The Odyssey laser system is unique in that it enables the user to easily alternate
between two pulse widths, thus offering a variety of ablative effects.
350 µs: higher peak power; optimal for ablation, but may cause stone migration.
700 µs: lower peak power; optimal for coagulation, also minimizes stone migration.
Selection of the pulse width depends on the given procedure. When operating on
soft tissue 700 µs will provide more thermal effect and cause less bleeding than
350 µs.
For Lithotripsy there are two main methodologies:
• “Break-up the stone” and extract the particulates with a basket or grasper. To
achieve this, use the 350 µs pulse width with a high energy level (J) and low
repitition rate (Hz). The repeated extraction of larger particulates may cause
more trauma to surrounding tissue.
•
“Dust the stone” and allow small particulates to void or irrigate easily during
the procedure. To achieve this, use a low energy level (J) and a high repitition
rate (Hz).
To select the optimal power parameters for a given target:
1 Select the pulse width based on expected migration and/or desired affect.
2 Set the parameters to 5 Hz/0.6 J.
3 Lase for a few seconds to observe the particulate size. Adjust Energy for
desired affect: higher energy will produce large, coarse particulates while
lower energy will produce finer particulates. Note that the fluence, or energy
density, is the operating parameter and depends on the chosen fiber type and
distance of the distal end from the operating plane.
4 Increase the repetition rate. This setting may be set as high as possible while
maintaining visibility of the target. The repetition rate governs the rate of
energy delivery. In general, higher repetition rates mean shorter operating
times when using the dusting method.
5 The laser system automatically calculates the average power by multiplying
the pulse energy with the repetition rate. Keep in mind that certain
combinations of pulse energy and repetition rate are not possible. Please
consult the power matrix listed in this chapter for available power settings.
51
52
CHAPTER 6
Operation
Treatment
1 Set the laser system to Ready state by pressing the Ready button located
on the control panel. The green Ready light will be lit. After two seconds the
display will indicate that the Laser is in Ready.
2 Carefully position the fiber-optic probe at or near the intended surgical site.
3 Adjust the aiming beam intensity by using the UP/DOWN arrows on the touch
screen display.
4 Aim and steady the distal end of the fiber at the surgical target.
5 Depress the foot switch when laser energy is desired. The Joules counter adds
the amount of energy delivered. Adjust power as necessary.
6 Return the laser system to Standby state by pressing the Standby button.
!
The laser system automatically returns to Standby state when changing any power
parameter.
Shut-down Sequence
1 Note the clinical parameters and Joule count as necessary.
2 Disconnect and dispose of the delivery system.
3 Close the laser aperture door by sliding the handle down.
4 Turn the key switch to the OFF position.
5 Remove the key from the key switch and store in safe place to protect against
unauthorized use of the laser.
6 Turn OFF the MAINS switch.
7 Unplug the power cord from the wall outlet.
8 Cover the laser system with the dust cover and store in a safe, dry area.
Odyssey 30 B User’s Manual
CHAPTER 6
Operation
53
Resetting the Emergency Stop
1 Verify that the MAINS switch is in the OFF position.
2 Verify that the key switch is in the OFF position.
3 Twist counterclockwise to release the emergency stop button.
4 Turn ON the MAINS switch.
5 Turn ON the key switch.
The laser system will not power ON unless the latching emergency stop button is
in the UP (released) position.
!
54
CHAPTER 6
Operation
This page intentionally left blank.
Odyssey 30 B User’s Manual
55
7
Maintenance
56
CHAPTER 7
Maintenance
Preventive Maintenance
The Odyssey has been designed to operate trouble free for thousands of
procedures. To maintain peak performance, the laser system should undergo a
preventive maintenance procedure every six to twelve months depending on
usage. The procedure should also be repeated if the laser system has not been
used for over two months.
The preventive maintenance procedures are as follows:
• inspect and replace cooling water if necessary
!
•
inspect and replace water filter if necessary
•
inspect and replace blast shield if necessary
•
clean optics
•
verify optical alignment and resonator tune
•
verify power calibration
•
inspect and replace air filter if necessary
Only an authorized service technician may conduct the preventive maintenance
procedures.
Other Regular Maintenance
Users and technicians are encouraged to maintain the appearance of the laser and
UPS by regularly cleaning the external surfaces with alcohol or a damp cloth.
Consult the UPS user manual for any needed preventive maintenance. Failure to
maintain the UPS may cause damage to the laser system.
Odyssey 30 B User’s Manual
CHAPTER 7
Maintenance
Troubleshooting Error Codes
Code Description
Probable Cause
Solution
03
WARNING: Optical deck
interlock override
Optical deck interlock
override switch engaged.
Call for service.
07
WARNING: Energy
output 20% below set
point
Laser resonator out
Continue Procedure;
of alignment or laser
call for service at next
resonator mirror damaged. opportunity.
08
WARNING: Energy
output 20% above set
point
System requires
re-calibration
11
Cooling water over
temperature (above
38 C, 100 °F)
Place system in Standby
Ambient operating room
temperature has exceeded state until error
disappears or lower
24 C (74° F).
ambient temperature.
12
14
Laser operating duty cycle
exceeded.
Place system in Standby
state until error
disappears or lower
output power.
Cooling system
component failure.
Call for service.
Foot switch stuck; foot
switch in down position
while attempting to
place system in Ready
state
An object is causing the
foot switch to remain in
the down position
Check foot switch for
obstruction
Foot switch failure
Replace foot switch.
Top Panel Interlock
disengaged
Top panel signal connector Call for service.
is not properly connected.
Top Panel Connector is
damaged.
15
Continue procedure;
call for service at next
opportunity.
Optical deck interlock
error
Call for service.
Optical deck covers are not Call for service.
properly seated or optical
deck interlock failure.
57
58
CHAPTER 7
Maintenance
Code Description
Probable Cause
Solution
16
An appropriate delivery
system is not in place.
Verify that the delivery
system uses a Convergent
compatible connector.
Fiber is faulty or heavily
damaged.
Replace fiber.
Remote connector
missing.
Verify that the remote
connector, located on
the back panel, is seated
securely.
An external device caused
the remote interlock
circuit to disable the laser
system.
Re-engage the remote
interlock with the
external source
17
18
27
Delivery system not
connected
Remote interlock open
Foot switch not
connected
Blast shield error
Verify that the connector
is screwed down finger
tight.
An appropriate foot switch Verify that the foot switch
is not in place.
connector, located on
the back panel, is seated
securely.
The foot switch connector
is damaged.
Call for service.
Blast shield motor or
optical sensor error.
Call for service.
Blast Shield installed
backwards.
Call for service.
28
Laser output below
minimun
Laser resonator out
Call for service.
of alignment or laser
resonator mirror damaged.
29
Laser output 100%
above set point
System requires
re-calibration.
See Power Calibration in
this chapter.
Error spike injected into
high power electronics.
Turn OFF laser system
and restart after
30 seconds.
Odyssey 30 B User’s Manual
CHAPTER 7
Maintenance
Code Description
Probable Cause
Solution
30
Cooling fan failure
Cooling fans operating
below performance.
Continue procedure;
call for service at next
opportunity.
32
IGBT falure
High power electronics
failure.
Turn OFF laser system
and restart after
30 seconds; if error
persists, call for service.
34
Main power supply
overload
Low line voltage condition Verify that the voltage
causes power supply to
meets the performance
draw too much current.
specifications in
Chapter 2.
Component failure.
Call for service.
35
Main power supply over
temperature
Power supply cooling fan
failure.
Call for service.
37
Laser timer repitition
rate errror
Laser timer error.
Turn OFF laser system
and restart after
30 seconds; if error
persists, call for service.
38
Laser timer pulse width
error
Laser timer error.
Turn OFF laser system
and restart after
30 seconds; if error
persists, call for service.
42
Main power supply
charge error
Power supply or capacitor
bank failure
Turn OFF laser system
and restart after
30 seconds; if error
persists, call for service.
44
Safety shutter error
Safety shutter stuck in
incorrect position.
Call for service.
Safety shutter sensor error. Call for service.
59
60
CHAPTER 7
Maintenance
Code Description
Probable Cause
Solution
46
Low line supply voltage
condition.
Verify that the supply
voltage meets
the performance
specifications in
Chapter 2.
Flash lamp failure.
Turn OFF laser system
and restart after
30 seconds; if error
persists, call for service.
Laser flash lamp simmer
error
50
Foot switch error
Foot switch in short circuit
situation or foot switch
failure.
Replace foot switch.
52
Computer error
At least one
microcontroler has
stopped responding.
Turn OFF laser system
and restart after
30 seconds; if error
persists, call for service.
53
External watchdog error
External watchdog
microcontroler failed to
communicate with the
main computer.
Turn OFF laser system
and restart after
30 seconds; if error
persists, call for service.
56
Laser cavity water
pressure error
Preventive maintenance
procedure needed.
Call for service.
Water pressure across laser Call for service.
cavity is out of range.
57
Cooling water flow rate
error
Odyssey 30 B User’s Manual
Cavity pressure sensor
error.
Call for service.
Error 56 has occurred.
Call for service.
Water pump failure.
Call for service.
Cooling system leaking.
Call for service.
Water flow rate sensor
failure.
Call for service.
CHAPTER 7
Maintenance
Troubleshooting Problems Without Error Codes
•
Laser returns to Standby without giving an Error Code: re-enter ready. Call for
service if this issue continues.
•
Reconnect Fiber: if a delivery system is in place before the laser is powered
ON, the touch screen will indicate that the fiber must be reconnected. Simply
remove the fiber from the aperture, then reconnect it to the laser system.
•
System boots to Pass Code screen: if the foot switch is depressed when the
laser powers ON it will enter service mode and request the pass code. To exit,
disengage or disconnect the footswitch and restart the laser. If the system
continues to enter service mode call for service.
•
Touch Screen Failure: shut down the laser system, wait several seconds before
restarting. Call for service if the problem persists.
•
The MAINS Switch will not stay ON: verify that the Emergency Stop button is not
depressed. If the laser still will not power ON, call for service.
•
Laser system will not power ON: verify that the laser is plugged in. If the laser is
plugged in and will not power ON, call a technician to verify that the supply
power is sufficient. If this problem persists call for service.
•
Laser system damages fibers: rotate the blast shield and connect a new,
undamaged fiber. If the problem persists call for service.
61
62
CHAPTER 7
Maintenance
Blast Shield Maintenance
The Odyssey is preinstalled with a blast shield to protect the output lens from
flashback debris. There are six blast shields per disk. After one blast shield is soiled,
the next one can be activated simply by rotating the disk to the next position from
the user power setting screen. After the last blast shield is exhausted, the blast
shield disk will have to be replaced. A new blast shield may be ordered by calling
the manufacturer and requesting part number LP7105.
Under normal operating conditions, a blast shield should last for over 100 cases.
Typically, a blast shield gets soiled for the following reasons:
!
•
the delivery system connector face became soiled due to mishandling
•
the internal optical system became misaligned
•
an inappropriate delivery system was used
Using another manufacturer’s delivery system on the Odyssey may damage the
laser system and will void the manufacturer’s warranty.
Inspect the blast shield whenever you notice a drop in output power. This can be
noticed clinically—it takes a higher energy setting to achieve the same clinical
result—or verified quantitatively using an appropriate energy or power meter.
The following procedures expose the biomedical engineer to high voltages. Please
observe all safety precautions. The following procedures should only be attempted
by a qualified biomedical engineer or service technician.
Inspecting the Blast Shield
1 Enter service mode; avoid entering the calibration screen.
2 Turn ON the aiming beam without a fiber attached.
3 Place a piece of paper approximately 1-2 feet (30-60cm) in front of the open
laser aperture and inspect the interference pattern of the aiming beam.
4 A clean blast shield will have a very homogenous interference pattern.
Odyssey 30 B User’s Manual
CHAPTER 7
Maintenance
63
5 A soiled blast shield will have defects that look like pebbles thrown into calm
water.
6 Defects near the periphery do not indicate a soiled fiber.
A fractured blast shield could give a false “clean” interference pattern since the
optic is no longer present. If the blast shield was suspected to have damage, but
appears very clean, it may be fractured. For this reason, this procedure does not
replace regular preventive maintenance.
!
Once a soiled blast shield is discovered, inspect any recently used fibers for burnt
connector faces. Reusing a fiber with a damaged connector will systematically
destroy blast shields.
!
Power Calibration
As the laser system ages, the efficiency of certain components may decrease.
Power calibration should be verified as part of the preventive maintenance
program.
Only authorized service personnel may calibrate the laser system. The calibration
procedures permit access to service mode functions which, if used improperly,
may damage the laser system.
During calibration the ambient conditions and cooling water temperature must be
within the tolerated ranges.
•
the ambient temperature should be between 18-22° C (65-72 °F)
•
cooling water temperature must not exceed 29° C (84 °F)
Always conduct the calibration in a restricted access room with laser safety signs
posted at all entrances. Wear appropriate safety eye wear at all times during power
calibration.
1 Plug laser system into a 230 V~ electrical outlet. Power calibration can only be
conducted using a 230 V~ line input. Re-configure the transformer if necessary.
2 Turn the MAINS switch ON (I).
3 Simultaneously turn ON the key switch and depress the foot switch. This will
allow you to gain access to the software’s service mode functions.
64
CHAPTER 7
Maintenance
4 When prompted for the pass code, enter in the pass code supplied with your
laser system and touch the
!
button.
ENTER
The pass code is issued to the registered owner of the laser system. Please contact
customer service if you have forgotten or misplaced your pass code. Each laser
system has a unique pass code.
5 If the pass code is entered correctly, the service menu will be displayed on the
touch screen.
6 Insert a new 550 µm core fiber into the fiber-optic port.
7 Set up a compatible energy or power meter to read the laser output at the
distal end of the fiber.
8 Touch the calibration button
.
9 Referring to the power matrix in Chapter 6, step through each value and
confirm output power. The power setting should be within 10%.
10 If necessary, adjust the output power by increasing or decreasing the power
to
supply voltage. After the correct voltage is set, touch the save button
store the current value in static memory.
!
Do not set the power supply program voltage over 4.800 V.
11 Return to the service menu and then to the user power settings screen.
12 Step through each power setting and confirm output power. Note any
discrepancies and re-calibrate specific data points as necessary.
13 Verify the laser’s ability to launch energy into a small core fiber (273 µm).
!
Always verify every output power combination in user mode after calibration. An
incorrectly set data point may cause unexpected levels of output energy.
Odyssey 30 B User’s Manual
65
8
Customer Service
66
CHAPTER 8
Customer Service
Customer Service and Warranty
Customer Service, and warranty information for your Odyssey 30 Laser System are
offered by a Cook representative, or by an authorized distributor. Please review
the information provided by the distributor for details on customer service and
warranties offered.
Odyssey 30 B User’s Manual
67
Notes
68
Notes
Odyssey 30 B User’s Manual